510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
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Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
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Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
Unknown
The Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated is a subcutaneous continuous glucose monitoring sensor intended to determine glucose levels, direction, and rate of change in people with diabetes, factory-calibrated without requiring user calibration. This is a non-adjunctive device, meaning it is indicated to replace information from standard blood glucose monitoring to make diabetes treatment decisions, as well as providing historical glucose data. It is classified as a Class 3 device requiring Premarket Approval (PMA) due to its high-risk, non-adjunctive role in directing therapy; the regulation number field is not populated. The product code is PZE, reviewed by the Clinical Chemistry (CH) panel. It is not an implant and is not life-sustaining.
No 510(k) clearances found for "PZE". Try a different K-number, product code, or device name.
What is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.